Comparing Treatments for Multiple Myeloma

Exclusion Criteria

• •Prior bone marrow or PBSC transplant.
• •HIV positivity.
• •Extensive marrow fibrosis, non-aspirable marrow, myelodysplastic changes or greater than 30 percent marrow plasma cells.
• •Prior treatment with greater than 6 cycles of chemotherapy regimens containing alkylating agents such as melphalan, cyclophosphamide or BCNU.
• •History of another malignancy within 5 years of protocol entry, with the exception of localized carcinomas cured by surgical resection such as basal cell carcinoma, stage I breast or bladder cancer, or in situ carcinoma of the cervix.
• •Significant nonmalignant disease including uncontrolled hypertension, unstable angina, congestive heart failure, poorly controlled diabetes, coronary angioplasty within 6 months, myocardial infarction within 6 months, uncontrolled arrhythmias, or any other medical condition felt by the principal investigator to unduly increase the risk of autologous transplantation.
• •Significant allergy history: these criteria will be assessed via the Allergy History CRF Screening Form.
• •No history of positive allergy tests to insect venoms (either skin or RAST).
• •No history of seasonal or recurrent asthma within the preceding 10 years.
• •No asthmatic symptoms (e.g. wheezing) related to a current respiratory tract infection.
• •No anaphylactic/anaphylactoid-type event manifested by disseminated urticaria, laryngeal edema, and/or bronchospasm (or for example: food, insect bites, etc.) Patients with drug allergies, manifest solely by rash, and/or urticaria are not excluded.
• •No history of angioedema or recurrent urticaria (an isolated episode of urticaria is not a contraindication).
• •No active infection (including those with current symptoms of bronchoconstriction), or fever greater than or equal to 38.2 degrees Celsius.
• •No known allergy to E. coli-derived products.
• •No concurrent use of beta adrenergic blocking agents.
• •No concurrent use of other investigative agents.
• •No pregnancy or breast-feeding. Men and women of child-bearing potential, admitted to the trial are to be advised to take adequate measures to prevent conception.
• •Patients maintained on interferon, chemotherapy or hematopoietic growth factors must have these treatments discontinued for at least four weeks prior to entry into this study.